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Treatment of Apathy in Alzheimer's Disease With Modafinil

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ClinicalTrials.gov Identifier: NCT01172145
Recruitment Status : Completed
First Posted : July 29, 2010
Results First Posted : March 4, 2011
Last Update Posted : March 4, 2011
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Cephalon
Information provided by:
Brown University

Study Description
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Brief Summary:
This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).

Condition or disease Intervention/treatment Phase
Apathy Alzheimer's Disease Drug: Modafinil Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Apathy in Alzheimer's Disease With Modafinil
Study Start Date : July 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Cholinesterase inhibitor only Drug: Placebo
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Experimental: Cholinesterase Plus Modafinil Drug: Modafinil
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Other Name: Provigil


Outcome Measures
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Primary Outcome Measures :
  1. Apathy [ Time Frame: at baseline ]
    The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.

  2. Apathy [ Time Frame: after 8 weeks of treatment ]
    The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.


Secondary Outcome Measures :
  1. Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: at baseline ]
    Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.

  2. The Direct Assessment of Functional Status Scale [ Time Frame: at baseline ]
    A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.

  3. Zarit Burden Inventory [ Time Frame: at baseline ]
    Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.

  4. Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: after 8 weeks of treatment ]
    Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.

  5. The Direct Assessment of Functional Status Scale [ Time Frame: after 8 weeks of treatment ]
    A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.

  6. Zarit Burden Inventory [ Time Frame: after 8 weeks of treatment ]
    Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of mild to moderate stage Probable Alzheimer's disease
  • on a stable dose of a cholinesterase inhibitor medication for at least 30 days
  • clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale

Exclusion Criteria:

  • diagnosis of Major Depression
  • focal brain lesion on neuroimaging
  • history of significant substance abuse
  • history of significant head trauma with loss if consciousness >10 minutes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172145


Locations
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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
National Institute of Mental Health (NIMH)
Cephalon
Investigators
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Principal Investigator: Laura L Frakey, Ph.D. Memorial Hospital of Rhode Island
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laura L. Frakey, Brown University
ClinicalTrials.gov Identifier: NCT01172145    
Other Study ID Numbers: 1F32MH075583-01 ( U.S. NIH Grant/Contract )
1F32MH075583-01 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2010    Key Record Dates
Results First Posted: March 4, 2011
Last Update Posted: March 4, 2011
Last Verified: September 2010
Keywords provided by Brown University:
apathy
Alzheimer's disease
activities of daily living performance
caregiver burden
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
 Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action